# DEN160014: remOVE System

- Pathway: De Novo (Direct)
- Applicant: Ovesco Endoscopy AG
- Decided: Dec 22, 2017 after 620 days
- Product code: QAG (Endoscopic Electrosurgical Clip Cutting System)
- Device class: 2
- Regulation: 21 CFR 876.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The remOVE System consists of the DC Impulse and the DC Cutter Set. The remOVE DC Impulse is a medical electrical device for fragmentation of OTSC® (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD® (endoscopic device for full-thickness resection of colorectal wall lesions) clips made by Ovesco Endoscopy AG for the digestive tract. The remOVE DC Cutter Set is a set of instruments for use in flexible endoscopy. It consists of a bipolar DC instrument for the fragmentation of OTSC (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD (endoscopic device for full-thickness resection of colorectal wall lesion) clips from Ovesco Endoscopy AG, a pair of forceps and a cap for removal of these fragmented clips.

Source page: https://510kreport.com/device/DEN160014
Methodology: https://510kreport.com/methodology